1.Efficacy and safety of herbal medicine yun-cai tea in the treatment of hyperlipidemia: A double-blind placebo-controlled clinical trial.
Chien-Ying LEE ; Min-Chien YU ; Chun-Che LIN ; Ming-Yung LEE ; James Cheng-Chung WEI ; Hung-Che SHIH
Chinese journal of integrative medicine 2015;21(8):587-593
OBJECTIVEAnimal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effects and safety of yun-cai tea in patients with elevated lipid levels in a human clinical trial.
METHODSThis was a 12-week, randomly assigned, parallel-group, double-blind, and placebo-controlled pilot clinical study. Sixty primary hyperlipidemia patients were included and randomly assigned to the yun-cai tea group (30 patients) and the placebo group (30 patients), for 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint was changes in plasma low-density lipoprotein-cholesterol (LDL-C) at 8 weeks. The secondary endpoints included total cholesterol (TC) and triglycerides (TG).
RESULTSOur results revealed no statistically signifificant differences in LDL-C and TC between the two groups. Despite the lack of a statistically signifificant difference in the level of TG between the two groups, a declining trend was noted. A signifificant reduction of TG was observed in the yun-cai tea group at week 8, compared to baseline (P=0.048). The incidence of stomach discomfort, gastroesophageal reflfl ux, diarrhea, and constipation was slightly higher in the yun-cai tea group. No other signifificant adverse events were found.
CONCLUSIONIt is unlikely that yun-cai tea used had a blood lipid reduction effect. Further larger scale clinical trials with a longer duration and larger dose are necessary.
Adult ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Herbal Medicine ; Humans ; Hyperlipidemias ; drug therapy ; Hypolipidemic Agents ; therapeutic use ; Male ; Middle Aged ; Placebos
2.Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group
Chyong-Huey LAI ; Elizabeth VALLIKAD ; Hao LIN ; Lan-Yan YANG ; Shih-Ming JUNG ; Hsueh-Erh LIU ; Yu-Che OU ; Hung-Hsueh CHOU ; Cheng-Tao LIN ; Huei-Jean HUANG ; Kuan-Gen HUANG ; Jiantai QIU ; Yao-Ching HUNG ; Tzu-I WU ; Wei-Yang CHANG ; Kien-Thiam TAN ; Chiao-Yun LIN ; Angel CHAO ; Chee-Jen CHANG
Journal of Gynecologic Oncology 2020;31(1):e5-
Objectives:
An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer.
Methods:
Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m2, n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA/homologous recombination deficiency (HRD) genes, because BRCA/HRD mutations (BRCA/HRDm) are known to be associated with better prognosis.
Results:
Enrollment was slow, accrual was closed when 7+ years had passed. With a medianfollow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19–0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA/HRDm was not significantly biased between the two arms. Wild-type BRCAon-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11–1.18; p=0.091).
Conclusions
Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.
3.Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group
Chyong Huey LAI ; Elizabeth VALLIKAD ; Hao LIN ; Lan Yan YANG ; Shih Ming JUNG ; Hsueh Erh LIU ; Yu Che OU ; Hung Hsueh CHOU ; Cheng Tao LIN ; Huei Jean HUANG ; Kuan Gen HUANG ; Jiantai QIU ; Yao Ching HUNG ; Tzu I WU ; Wei Yang CHANG ; Kien Thiam TAN ; Chiao Yun LIN ; Angel CHAO ; Chee Jen CHANG
Journal of Gynecologic Oncology 2020;31(1):5-
4.Management of ulcerative colitis in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease updated in 2023
Hsu-Heng YEN ; Jia-Feng WU ; Horng-Yuan WANG ; Ting-An CHANG ; Chung-Hsin CHANG ; Chen-Wang CHANG ; Te-Hsin CHAO ; Jen-Wei CHOU ; Yenn-Hwei CHOU ; Chiao-Hsiung CHUANG ; Wen-Hung HSU ; Tzu-Chi HSU ; Tien-Yu HUANG ; Tsung-I HUNG ; Puo-Hsien LE ; Chun-Che LIN ; Chun-Chi LIN ; Ching-Pin LIN ; Jen-Kou LIN ; Wei-Chen LIN ; Yen-Hsuan NI ; Ming-Jium SHIEH ; I-Lun SHIH ; Chia-Tung SHUN ; Tzung-Jiun TSAI ; Cheng-Yi WANG ; Meng-Tzu WENG ; Jau-Min WONG ; Deng-Chyang WU ; Shu-Chen WEI
Intestinal Research 2024;22(3):213-249
Ulcerative colitis (UC) is a chronic inflammation of the gastrointestinal tract and is characterized by alternating periods of inflammation and remission. Although UC incidence is lower in Taiwan than in Western countries, its impact remains considerable, demanding updated guidelines for addressing local healthcare challenges and patient needs. The revised guidelines employ international standards and recent research, emphasizing practical implementation within the Taiwanese healthcare system. Since the inception of the guidelines in 2017, the Taiwan Society of Inflammatory Bowel Disease has acknowledged the need for ongoing revisions to incorporate emerging therapeutic options and evolving disease management practices. This updated guideline aims to align UC management with local contexts, ensuring comprehensive and context-specific recommendations, thereby raising the standard of care for UC patients in Taiwan. By adapting and optimizing international protocols for local relevance, these efforts seek to enhance health outcomes for patients with UC.
5.Management of Crohn’s disease in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease updated in 2023
Jia-Feng WU ; Hsu-Heng YEN ; Horng-Yuan WANG ; Ting-An CHANG ; Chung-Hsin CHANG ; Chen-Wang CHANG ; Te-Hsin CHAO ; Jen-Wei CHOU ; Yenn-Hwei CHOU ; Chiao-Hsiung CHUANG ; Wen-Hung HSU ; Tzu-Chi HSU ; Tien-Yu HUANG ; Tsung-I HUNG ; Puo-Hsien LE ; Chun-Che LIN ; Chun-Chi LIN ; Ching-Pin LIN ; Jen-Kou LIN ; Wei-Chen LIN ; Yen-Hsuan NI ; Ming-Jium SHIEH ; I-Lun SHIH ; Chia-Tung SHUN ; Tzung-Jiun TSAI ; Cheng-Yi WANG ; Meng-Tzu WENG ; Jau-Min WONG ; Deng-Chyang WU ; Shu-Chen WEI
Intestinal Research 2024;22(3):250-285
Crohn’s disease (CD) is a chronic, fluctuating inflammatory condition that primarily affects the gastrointestinal tract. Although the incidence of CD in Taiwan is lower than that in Western countries, the severity of CD presentation appears to be similar between Asia and the West. This observation indicates the urgency for devising revised guidelines tailored to the unique reimbursement system, and patient requirements in Taiwan. The core objectives of these updated guidelines include the updated treatment choices and the integration of the treat-to-target strategy into CD management, promoting the achievement of deep remission to mitigate complications and enhance the overall quality of life. Given the diversity in disease prevalence, severity, insurance policies, and access to medical treatments in Taiwan, a customized approach is imperative for formulating these guidelines. Such tailored strategies ensure that international standards are not only adapted but also optimized to local contexts. Since the inception of its initial guidelines in 2017, the Taiwan Society of Inflammatory Bowel Disease (TSIBD) has acknowledged the importance of continuous revisions for incorporating new therapeutic options and evolving disease management practices. The latest update leverages international standards and recent research findings focused on practical implementation within the Taiwanese healthcare system.
6.No additional cholesterol-lowering effect observed in the combined treatment of red yeast rice and Lactobacillus casei in hyperlipidemic patients: A double-blind randomized controlled clinical trial.
Chien-Ying LEE ; Min-Chien YU ; Wu-Tsun PERNG ; Chun-Che LIN ; Ming-Yung LEE ; Ya-Lan CHANG ; Ya-Yun LAI ; Yi-Ching LEE ; Yu-Hsiang KUAN ; James Cheng-Chung WEI ; Hung-Che SHIH
Chinese journal of integrative medicine 2017;23(8):581-588
OBJECTIVETo observe the effect of combining red yeast rice and Lactobacillus casei (L. casei) in lowering cholesterol in patients with primary hyperlipidemia, the later has also been shown to remove cholesterol in in vitro studies.
METHODSA double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L. casei. Sixty patients with primary hyperlipidemia were recruited and randomized equally to either the treatment group (red yeast rice + L. casei) or the control group (red yeast rice + placebo). One red yeast rice capsule and two L. casei capsules were taken twice a day. The treatment lasted for 8 weeks, with an extended follow-up period of 4 weeks. The primary endpoint was a difference of serum low-density lipoprotein cholesterol (LDL-C) level at week 8.
RESULTSAt week 8, the LDL-C serum level in both groups was lower than that at baseline, with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group; however, there was no statistical difference between the two groups (P>0.05). The total cholesterol was also lower than the baseline in both groups, yet without a statistical difference between the two groups. The only statistically signifificant difference between the two groups was the average diastolic pressure at week 12, which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group (P<0.05). The antihypertensive activity may be associated with L. casei. Red yeast rice can signifificantly reduce LDL-C, total cholesterol and triglyceride.
CONCLUSIONThe combination of red yeast rice and L. casei did not have an additional effect on lipid profifiles.
7.Evaluation of the potential inhibitory activity of a combination of L. acidophilus, L. rhamnosus and L. sporogenes on Helicobacter pylori: A randomized double-blind placebo-controlled clinical trial.
Chien-Ying LEE ; Hung-Che SHIH ; Min-Chien YU ; Ming-Yung LEE ; Ya-Lan CHANG ; Ya-Yun LAI ; Yi-Ching LEE ; Yu-Hsiang KUAN ; Chun-Che LIN
Chinese journal of integrative medicine 2017;23(3):176-182
OBJECTIVESTo investigate whether three strains of probiotics, L. acidophilus, L. rhamnosus, and L. sporogenes, had signifificant inhibitive effects on Helicobacter pylori (H. pylori).
METHODSThis is a 4-week, randomly assigned, parallel-group, doubled-blind, and placebo-controlled study. Fifty patients with a positive H. pylori infection urea breath test (△UBT) result > 10% and without ulcer symptoms were randomized into a treatment group and a placebo group by a computer generated allocation sheet with 1:1. These subjects took one capsule of probiotics or placebo twice daily. The primary measurement was the change in △UBT values.
RESULTSThe △UBT values during the 4-week treatment period and the 2-week follow-up period were not signifificantly different between the treatment group and the placebo group, indicating that the inhibitive effects on H. pylori were comparable between both groups. The monocyte count (%) was 5.77±1.11 in the treatment group versus 5.09±1.12 in the placebo group (P=0.044), and the basophile count was 0.55±0.32 in the treatment group versus 0.36±0.23 in the placebo group (P=0.024) at week 2 of the treatment period, both of which reached statistical signifificance. The monocyte count was 5.75±1.26 in the treatment group and 4.72±0.99 in the placebo group at the end of the follow-up period (P=0.003).
CONCLUSIONThere was no signifificant inhibitive effects of the three probiotic strains (L. acidophilus, L. rhamnosus, and L. sporogenes) on H. pylori. Probiotics can not play the same role as antibiotics in the eradication of H. pylori, the role of probiotics is likely to be important as adjuvant to the triple or quadruple therapy for H. pylori, especially in resistance cases.
Adult ; Aged ; Breath Tests ; Demography ; Double-Blind Method ; Endpoint Determination ; Female ; Helicobacter pylori ; drug effects ; Humans ; Lactobacillus ; metabolism ; Male ; Middle Aged ; Probiotics ; administration & dosage ; adverse effects ; pharmacology ; Urea ; analysis ; Young Adult